Pharmacovigilance Scientist at R&D Partners Cambridge, MA

R&D Partners; Cambridge (MA); On-site; USD 103,292 - 112,274; Full time

Benefits offered by this job

Medical insurance PPO, HMO & HSA

Dental & Vision insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Expense reimbursement

Online timecard approval

Job summary

R&D Partners is looking for a Pharmacovigilance Scientist in Cambridge, MA, to analyze and manage safety issues. Responsibilities include collaborating with safety physicians and preparing safety reports. Requirements include a relevant degree, 3-5 years in drug safety, and experience with ARGUS and Empirica. The position offers a salary range of $74.98 to $81.50, depending on experience, alongside benefits like medical and dental insurance, 401k plan, and more.

Qualifications

• A minimum of three to five years in the pharmaceutical industry.
• Experience in drug safety/pharmacovigilance is essential.
• Authoring experience is needed.

Responsibilities

• Work closely with safety physician on safety issues.
• Perform signaling data review from various sources.
• Manage authoring for aggregate safety reports.

Skills

Clinical background

Analytic skills

Experience in drug safety/pharmacovigilance

Education

Degree in a medical or healthcare related discipline

Tools

ARGUS

Empirica

Job description

Job Description

R&D Partners is seeking to hire a Pharmacovigilance Scientist in Cambridge, MA.

Your main responsibilities as a Pharmacovigilance Scientist:

• Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management
• Contribute to signaling and data mining activities utilizing internal and external sources of data
• Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates
• Together with safety physician manages leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions
• Supports all SRMT preparation and documentation with guidance from mentor and safety physician
• Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties
• Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes, and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues

What we are looking for in a Pharmacovigilance Scientist:

• Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required
• A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance
• ARGUS and Empirica PSUR, DSUR for Aggerate reporting
• Must have clinical background
• Authoring experienceVery analytic

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long‑term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Salary:

• $74.98 to $81.50 (Dependent on Experience)

R&D Partners is an equal‑opportunity employer.